FDA.reportPublic FDA data

Rascal Carbon Cruiser

Primary DI
00606509500388
Brand
Rascal Carbon Cruiser
Company
Pride Mobility Products Corp
Model
Rascal Carbon Cruiser
Catalog number
N/A
Device description
The Power Wheelchair (N5515B) is a motor driven, indoor and outdoor transportation vehicle with the intended use toprovide mobility to a disabled or elderly person limited to a seated position.
Published
2025-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220747000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220747000Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2022-05-12ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606509500388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606509500388006065095003886065095003880606509500388

GMDN Terms#

Term, Definition table
TermDefinition
Electric-motor-driven wheelchair, occupant-controlledAn electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041477449
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606509500449Rascal CruiserRascal CruiserN/A2026-09-18
00606509500432MM3635MM3635N/A2026-09-04
00606509300919Go Go Super Portable 2SC15M2N/A2026-03-19
00606509300926Go Go Super Portable HDSC15HDN/A2026-03-19
00606509300865Baja Wrangler 3BA403N/A2026-02-17
00606509300872Ultra X GEN 3SC493N/A2026-02-17
00606509300889Elite Traveller GEN 3SC443EN/A2026-02-17
00606509300896Elite Traveller GEN 3 PlatinumSC443EMSN/A2026-02-17
00606509500418MM5401MM5401N/A2026-02-03
00606509500425MM5640MM5640N/A2026-02-03
00606509100403Jazzy EVO 613 AirJazzy EVO 613 AirN/A2025-11-14
00606509401685LC435PWLC435PWN/A2025-11-14
00606509100380Jazzy Carbon 27Jazzy Carbon 27N/A2025-10-10
00606509100397Jazzy Carbon HDJazzy Carbon HDN/A2025-10-10
00606509500401MM6420MM6420N/A2025-09-05
00606509100373Jazzy Carbon 27 XJazzy Carbon 27 XN/A2025-08-08
00606509500395MM8955MM8955N/A2025-08-07
00606509500326MM3600MM3600N/A2025-08-05
00606509500371MM8945MM8945N/A2025-08-05
00606509200288Q6 Edge 4Q6 Edge 4N/A2025-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841447198116INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198123INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198130INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198147INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198154INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198161INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198178INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198185INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198192INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198208INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198215INVACARE® PRONTO® 31 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198222INVACARE® PRONTO® 31 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198239INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGINVACARE CORPORATIONITI2026-09-20
00841447198246INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGINVACARE CORPORATIONITI2026-09-20
00841447198253INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198260INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198277INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198284INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198291INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198307INVACARE® PRONTO® M41™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198314INVACARE® PRONTO® M51™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198321INVACARE® PRONTO® M41™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198338INVACARE® PRONTO® M51™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198345INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198352INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198369INVACARE® 3G STORM SERIES® ARROW® POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198376INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198383INVACARE® 3G STORM SERIES® TORQUE™ SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198390INVACARE® TDX® SR POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198406INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20